Senior Manager, Medical Writing - Biotech - Remote USA
Proclinical is currently recruiting for a Senior Manager of Medical Writing for a biotechnology company located in Cambridge, MA, but the position is remotely based. Successful candidate will collaborate with project teams on the development of clinical documents in accordance with all applicable regulations, Good Clinical Practices, and Standard Operating Procedures (SOPs) and will oversee the work of contract writers on the clinical program.
- Produce high quality and on-time writing deliverables.
- Independently plan, write, edit, and format key documents, including clinical protocols, investigator brochures, clinical study reports, integrated safety and efficacy summaries and related documents.
- Facilitate/manage efficient review and finalization process for documents produced internally and/or externally by consultants, contractors and vendors.
- Represent Medical Writing on multiple early phase project teams or on specific late phase project teams and collaborate with the Director of Medical Writing to ensure proper planning and resourcing for upcoming project writing deliverables.
- Collaborate effectively with Biometrics, Clinical Operations, Clinical Development, Regulatory Affairs, Pre-Clinical Development, Program Management, Research, Quality, and Corporate Communications, as well as with external stakeholders.
- Serve as subject matter expert for clinical documents and their production.
- Contribute to SOP and template development and maintenance.
Skills and Requirements:
- Bachelor's degree in Life Science with relevant writing expertise or in English/Communications with relevant science expertise. Advanced degree and/or professional certification/credentials preferred.
- 5+ years of experience as a medical writer in the sponsor and/or CRO setting. Experience with regulatory submissions (CTA/IND/NDA/BLA) and knowledge of eCTD formatting is a plus.
- In-depth knowledge of Good Clinical Practices, FDA regulations, ICH guidelines, and the drug development process.
- Successful track record of managing multiple projects in a fast-paced and deadline-driven environment.
- Impeccable attention to detail and ability to complete writing assignments in a timely manner.
- Experience overseeing the work of contract writers is a plus.
- Must be proficient with Microsoft Windows, Word, Excel, and PowerPoint.
- Ability to travel approximately 10% is required.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call George Watson at (+1) 929-223-4835 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.